A Study of MT-2111 in Patients With Relapsed/Refractory DLBCL

February 11, 2026 updated by: Tanabe Pharma Corporation

A Phase I/II Open-Label Study of MT-2111 in Patients With Relapsed/Refractory DLBCL

[Phase I part] To investigate the safety, tolerability, and pharmacokinetics of MT-2111 monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In addition, the dose to be used in the Phase II part will be confirmed.

[Phase II part] To evaluate the efficacy of MT-2111 monotherapy in patients with relapsed/refractory DLBCL. In addition, the safety and pharmacokinetics will be investigated.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8650
        • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
      • Nagoya, Aichi-ken, Japan, 460-0001
        • Nagoya Medical Center
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 811-1395
        • Kyushu Cancer Center
      • Iizuka-shi, Fukuoka, Japan, 820-8505
        • Aso Iizuka Hospital
    • Fukushima
      • Fukushima, Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital
    • Gifu
      • Gifu, Gifu, Japan, 500-8513
        • Gifu Municipal Hospital
    • Gunma
      • Ota-shi, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • Hokkaido Cancer Center
    • Hyōgo
      • Himeji-shi, Hyōgo, Japan, 670-8540
        • Japanese Red Cross Society Himeji Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center
    • Kyoto
      • Kyoto, Kyoto, Japan, 602-8566
        • University Hospital, Kyoto Prefectural University of Medicine
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Nagano
      • Matsumoto-shi, Nagano, Japan, 390-8621
        • Shinshu University Hospital
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8104
        • Japanese Red Cross Nagasaki Genbaku Hospital
    • Osaka
      • Osaka, Osaka, Japan, 530-0012
        • Osaka Saiseikai Nakatsu Hospital
      • Osaka, Osaka, Japan, 530-0025
        • Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofukai
    • Shimane
      • Izumo-shi, Shimane, Japan, 693-8501
        • Shimane University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8677
        • Tokyo Metropolitan Komagome Hospital
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Koto-ku, Tokyo, Japan, 135-0063
        • Cancer Institute Hospital of JFCR
      • Tachikawa-shi, Tokyo, Japan, 190-0014
        • Disaster Medical Center
    • Yamagata
      • Yamagata, Yamagata, Japan, 990-9585
        • Yamagata University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who were diagnosed pathologically with DLBCL, NOS, DLBCL transformed from indolent B-cell lymphoma, or high-grade B-cell lymphoma with DLBCL morphology and with MYC and BCL2 and/or BCL6 rearrangements, based on the 2017 WHO classification.
  • Patients with relapsed or refractory disease despite 2 or more prior systemic therapies.
  • Japanese patients aged ≥ 18 years at the time of informed consent. For Japanese subjects, it should be confirmed that the parents who are related by blood to the subject must be Japanese.
  • Patients who have a lesion that can be assessed for staging and evaluated for response according to the Lugano criteria (2014). A lesion that has received radiotherapy as the most recent treatment will be considered as a measurable lesion only when progression has been documented following completion of the radiotherapy.
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening.

Exclusion Criteria:

  • Patients with a pathological diagnosis of Burkitt's lymphoma.
  • Patients with bulky disease with the longest dimension of ≥ 10 cm.
  • Patients with a history or complication of post-transplant lymphoproliferative disorders.
  • Patients with lymphoma with active central nervous system involvement at the time of screening, including leptomeningeal disease.

  • Patients complicated with other active malignancies or patients with a history of other malignancies within 3 years before informed consent. However, the following are exceptional:

    • Non-melanoma skin cancer
    • Non-metastatic prostate cancer
    • Cervical carcinoma in situ
    • Ductal carcinoma in situ or lobular carcinoma in situ
  • Patients with clinically significant third space fluid accumulation (e.g., ascites requiring drainage or pleural effusion requiring drainage or associated with shortness of breath).
  • Patients who underwent autologous hematopoietic stem cell transplantation (AHSCT) within 30 days prior to the start of study drug administration (Cycle 1 Day 1).
  • For the Phase I part, patients with prior allogeneic stem cell transplantation (Allo-HSCT) before the start of study drug administration (Cycle 1 Day 1). For the Phase II part, patients undergoing Allo-HSCT within 60 days prior to the start of study drug administration (Cycle 1 Day 1).
  • Patients who had a positive HIV antigen-antibody test or HIV antibody test.

  • Patients positive for HBs antigen, HBc antibody, or HBs antibody. However, patients who meet any of the following are eligible:

    • The patient's HBs antibody positivity is clearly due to vaccination.
    • Patients who are positive for HBs antibody and/or HBc antibody with HBV-DNA not detected and agree to undergo HBV-DNA tests once a month from the start of study drug administration to at least 12 months after the completion of study drug administration.
  • Patients positive for HCV antibody. However, patients with negative HCV-RNA are eligible.

  • Patients who received anticancer therapy during the following periods prior to the start of study drug administration (Cycle 1 Day 1).

    • Cytotoxic chemotherapy: within 14 days.
    • Antibody therapy: within 5 half-lives or 14 days, whichever is longer (including monoclonal antibody preparations, radioimmunoconjugates, or antibody-drug conjugates). Within 14 days for rituximab, anti-CD3/CD20 bispecific antibody.
    • Radiotherapy: within 14 days
    • CAR-T therapy: within 100 days
    • Other anticancer therapy: within 14 days
  • Patients who received treatment with any other investigational product within 14 days prior to the start of study drug administration (Cycle 1 Day 1). However, for the Phase I part, patients who received any other investigational product within 14 days or 5 half-lives, whichever is longer, before the start of study drug administration (Cycle 1 Day 1).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MT-2111 dosing regimen
Drug: MT-2111
i.v. infusion
Other Names:
  • Loncastuximab tesirine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate (ORR) by independent central review
Time Frame: From the date of the first dose of treatment until the date of discontinuation or completion of the study (Up to 48 months)
From the date of the first dose of treatment until the date of discontinuation or completion of the study (Up to 48 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response (DOR)
Time Frame: The time from the date of first observation of complete response (CR) or partial response (PR) until progressive disease (PD) or death in patients with CR or PR observed (Up to 48 months)
The time from the date of first observation of complete response (CR) or partial response (PR) until progressive disease (PD) or death in patients with CR or PR observed (Up to 48 months)
Overall survival (OS)
Time Frame: The time from the date of first dose until death regardless of the occurrence of intercurrent event (Up to 48 months)
The time from the date of first dose until death regardless of the occurrence of intercurrent event (Up to 48 months)
Progression-free survival (PFS)
Time Frame: The time from the date of first dose until PD or death (Up to 48 months)
The time from the date of first dose until PD or death (Up to 48 months)
Relapse-free survival (RFS)
Time Frame: The time from the date of first observation of CR until PD or death in patients with CR observed (Up to 48 months)
The time from the date of first observation of CR until PD or death in patients with CR observed (Up to 48 months)
Adverse events and adverse drug reactions
Time Frame: From the start of premedication until 15 weeks after the last dose of the study drug or until the start of new anticancer therapy, whichever comes first.
From the start of premedication until 15 weeks after the last dose of the study drug or until the start of new anticancer therapy, whichever comes first.
Eastern Cooperative Oncology Group (ECOG) Performance Status
Time Frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
ECOG (Eastern Cooperative Oncology Group) Performance Status is scored on a 6-point scale where higher scores indicate a worse outcome.
Screening to end of treatment (up to 30 days after the last dose) or data cut off
Body weight
Time Frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
Screening to end of treatment (up to 30 days after the last dose) or data cut off
12-lead electrocardiogram (heart rate)
Time Frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
Screening to end of treatment (up to 30 days after the last dose) or data cut off
12-lead electrocardiogram [RR, PR, QRS, QT (QTcF)]
Time Frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
Screening to end of treatment (up to 30 days after the last dose) or data cut off
12-lead electrocardiogram (presence or absence of abnormal findings)
Time Frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
Screening to end of treatment (up to 30 days after the last dose) or data cut off
Complete response rate (CRR)
Time Frame: From the date of the first dose of treatment until the date of discontinuation or completion of the study (Up to 48 months)
From the date of the first dose of treatment until the date of discontinuation or completion of the study (Up to 48 months)
Serum drug concentration
Time Frame: Cycle 1 (each cycle is 3 weeks): Days 1, 2*, 5*, 8, and 15. Cycle 2: Days 1, 2*, 8, and 15. Cycle 3: Days 1 and 8*. Odd numbered Cycles: Day 1. End of treatment (up to 13 months after first dose), 15 weeks after the last dose. *Phase 1 only.

[Phase 1 part] Cycle 1 [each cycle is 3 weeks (21 days) in duration]: Day 1, 2, 5, 8 and 15, Cycle 2: Day 1, 2, 8 and 15, Cycle 3: Day 1 and 8, odd number Cycle: Day 1,end of treatment (EOT)*, and 15 weeks after the last dose [Phase 2 part] Cycle 1 and 2: Day 1, 8 and 15, odd number Cycle : Day 1, EOT*, and 15 weeks after the last dose

*: After the decision to discontinue treatment with study drug and prior to the start of any new anticancer therapy, the scheduled evaluations will be performed preferably 30 days after the last dose of study drug.（Up to 13 months after the first treatment）
Cycle 1 (each cycle is 3 weeks): Days 1, 2*, 5*, 8, and 15. Cycle 2: Days 1, 2*, 8, and 15. Cycle 3: Days 1 and 8*. Odd numbered Cycles: Day 1. End of treatment (up to 13 months after first dose), 15 weeks after the last dose. *Phase 1 only.
Anti-drug antibodies (including neutralizing antibodies)
Time Frame: Cycle 1 (each cycle is 3 weeks): Days 1 and 15. Cycle 2: Day 1. Odd numbered cycles: Day 1. End of Treatment (up to 13 months after first dose) and 15 weeks after the last dose.

[Phase 1 part] Cycle 1 [each cycle is 3 weeks (21 days) in duration]: Day 1 and 15, Cycle 2: Day 1, odd number Cycle: Day 1, end of treatment (EOT)*, and 15 weeks after the last dose [Phase 2 part] Cycle 1: Day 1 and 15, Cycle 2: Day 1, odd number Cycle : Day 1, EOT*, and 15 weeks after the last dose

*: After the decision to discontinue treatment with study drug and prior to the start of any new anticancer therapy, the scheduled evaluations will be performed preferably 30 days after the last dose of study drug.（Up to 13 months after the first treatment）
Cycle 1 (each cycle is 3 weeks): Days 1 and 15. Cycle 2: Day 1. Odd numbered cycles: Day 1. End of Treatment (up to 13 months after first dose) and 15 weeks after the last dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanabe Pharma Corporation

Investigators

  • Study Director: General Manager, Tanabe Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 20, 2022

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-2111-A-101
  • jRCT2021220031 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

When requested by a qualified researcher in the field of science or medicine, Tanabe Pharma Corporation will share clinical trial data that was collected from individual patients in a clinical trial with that researcher after a review committee of experts determines that such sharing is appropriate.

Access Criteria: Please refer to the following link for conditions and limitations for sharing data.

URL: https://www.tanabe-pharma.com/en/develop/protocol.html

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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